Label: ASPIRIN tablet

  • NDC Code(s): 57896-901-01, 57896-901-10, 57896-901-27
  • Packager: Geri-Care Pharmaceuticals, Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 8, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily relieves:

    • pain and fever of colds
    • headache
    • muscle pain
    • minor pain of arthritis
    • toothache
    • menstrual pain
  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

    • facial swelling
    • shock
    • hives
    • asthma (wheezing)

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if

    • you have asthma
    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for

    • gout
    • diabetes
    • arthritis

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding:
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
      • feel faint
    • ringing in the ears or a loss of hearing occurs
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not take more than directed
    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
    • children under 12 years: do not use unless directed by a doctor
  • Other information

    • use by expiration date on package
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • Inactive ingredient

    corn starch

  • Questions or comments?

    1-800-540-3765

  • Principal Display Panel

    NDC 57896-901-01

    GERI CARE®

    ASPIRIN
    325 mg (NSAID)

    PAIN RELIEVER / FEVER REDUCER

    REGULAR STRENGTH

    Compare to active ingredient
    in BAYER® Aspirin **

    100 TABLETS

    Actual Size

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
    SEAL UNDER CAP IS BROKEN OR MISSING

    **This product is not manufactured or distributed by Bayer AG, owner
    of the registered trademark Bayer® Aspirin.

    50844
    REV0122D24912

    DISTRIBUTED BY: GERI-CARE PHARMACEUTICAL CORP.
    1295 Towbin Ave., Lakewood, NJ 08701

    Geri Care 44-249

    Geri Care 44-249

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-901
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;249;ASPIRIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-901-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/04/1993
    2NDC:57896-901-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/04/1993
    3NDC:57896-901-27250 in 1 BOTTLE; Type 0: Not a Combination Product08/04/199308/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/04/1993
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(57896-901)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(57896-901)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(57896-901)